Bioequivalency Study of Zidovudine Under Fasting Conditions
Sponsor
Roxane Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT00602550
Collaborator
(none)
52
1
Study Details
Study Description
Brief Summary
The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
52 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Dose, Two Treatment, Two Period, Two Sequence, Crossover Bioequivalency Study of 300 mg Zidovudine Tablets Under Fasting Conditions
Study Start Date
:
Jun 1, 2003
Actual Primary Completion Date
:
Jun 1, 2003
Actual Study Completion Date
:
Jun 1, 2003
Outcome Measures
Primary Outcome Measures
- Bioequivalence [Baseline, Two period, Three day washout]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory findings during screening.
Exclusion Criteria:
-
Allergic or adverse responses to zidovudine or any other comparable or similar products.
-
Participation in clinical trial within 30 days of study initiation.
-
Positive blood screen for HIV, Hepatitis B and C.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CEDRA Clinical Research | Austin | Texas | United States | 78759 |
Sponsors and Collaborators
- Roxane Laboratories
Investigators
- Principal Investigator: Daniel V Freeland, DO, CEDRA Clinical Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00602550
Other Study ID Numbers:
- ZIDO-03
First Posted:
Jan 28, 2008
Last Update Posted:
Jan 23, 2018
Last Verified:
Jan 1, 2018